Class Class II

IPL Treatment Device (MDSQMC-01) (K243123)

K243123 2025-07-03 Traditional
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Description

IPL Treatment Device (MDSQMC-01) by Medusa (Guangxi)Medical Devices Co., Ltd., an FDA 510(k) cleared general, plastic surgery device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK243123
Clearance Date2025-07-03
Clearance TypeTraditional
Product CodeONF
Regulation Number878.4810

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Predicate lineage for K243123

A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. IPL Treatment Device (MDSQMC-01) (K243123) cites 3 predicate devices and is itself cited by 0 later devices.

Predicate devices cited by this clearance

Devices this clearance was compared against
K numberDeviceApplicantYear
K230816Intense Pulsed Light Treatment SystemShangdong Huamei Technology Co., Ltd.2023
K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemLumenis, Ltd.2020
K192519Multi-modality workstationBeijing Superlaser Technology Co., ...2019

Trace the full predicate network for K243123

A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.

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